Nature Biotechnology published an overview describing 2025 as a year of regulatory upheaval at the FDA: leadership changes, staff cuts and new policies impacted approval dynamics and the mix of novel versus follow‑on approvals. The piece documents agency shifts and how internal restructuring affected review throughput and industry interactions. The analysis notes a rise in follow‑on products versus first‑in‑class approvals and highlights implications for developers planning regulatory strategies in a changing oversight environment. The coverage recommends industry stakeholders anticipate policy shifts and engage regulators early to de‑risk development timelines. Why it matters: evolving FDA staffing and policy priorities affect go/no‑go decisions, trial design and timing for companies—especially small biotechs that rely on predictable review paths for commercialization.